A Randomized Split Scar Study of Suture Safe Treatment of Surgical Wounds to Minimize Scaring

NCT02620475 | Unknown

• 1 other identifier: H15-02683
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect SutureSafe dressings have on reducing scarring from an incision following an elective abdominoplasty (tummy tuck) procedure. The scar will be evaluated using subjective clinical assessment criteria. Each participant in the study will serve as a control and experiential study, since have of the incision will be treated with the gold standard of care and the other half with SutureSafe dressings.

Conditions

Scars

Outcome Measures

Primary Outcomes (1)

• Change between usual standard of care and experimental dressings at 3 months, 6 months and 1 year, assessed using the Vancouver Scar Score

  3 months, 6 months and 1 year post operative

Study Arms (2)

Gold standard of care

ACTIVE COMPARATOR

The usual gold standard of wound treatment to prevent scarring is to cover the incision with a self adhesive gauze type dressing (Mepore) covered by paper tape.

Device: SutureSafe

SutureSafe dressings

EXPERIMENTAL

SutureSafe dressing are designed to apply a constant gentle inward pressure on the incision to reduce separating tension on newly formed incisions, stabilizing the healing environment.

Device: SutureSafe

Interventions

SutureSafe DEVICE

SutureSafe dressing are designed to apply a constant gentle inward pressure on the incision to reduce separating tension on newly formed incisions, stabilizing the healing environment.

Gold standard of care; SutureSafe dressings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old and older
• Have undergone an abdominoplasty procedure by Dr. Nick Carr
• Have fitzpatrick skin type IV-VI
• Be willing and able to return for all study follow-up procedures
• Have not participated in any other investigational or invasive clinical trial within the last 30 days, and will not participate in any other investigational or invasive clinical trial during this study; and
• Have been informed of the nature of the study, agreeing to its requirements, and have signed the informed consent approved by the Research Ethics Board.

You may not qualify if:

• Are unable to meet the treatment and follow up protocol requirements.
• Less than 18 years of ageCo-morbidity that reduces life expectancy to less than 12 months
• Cannot use any other methods (i.e. parmaceuditcal, natural, homeopathic) medications or devices for scar treatment.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Skin Works

Vancouver, British Columbia, V6N 3E6, Canada

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nick Carr, B.Sc. MD

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

• Baillie L Redfern, B.Sc., M.Sc

  The University of British Columbia

  STUDY DIRECTOR

Central Study Contacts

Baillie L Redfern, B.Sc., M.Sc

CONTACT

6043622501; baillie.redfern@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: December 3, 2015
• Study Start: January 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: December 3, 2015

Record last verified: 2015-11

Locations

CA (1)